Ketamine Reduces Tourniquet Pain In Patients Undergoing Lower Limb Surgery Under Spinal Anaesthesia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- Change in pain scores among patients in ketamine group vs patients in saline group, for patients undergoing lower limb surgery under spinal anaesthesia.
研究概览
简要总结
A prospective, double blind, randomised controlled trial to evaluate the effect of ketamine in reducing tourniquet pain for patients undergoing lower limb surgery under spinal anaesthesia.
Secondary Objective To evaluate the effect of ketamine in attenuating TIH for patients undergoing lower limb surgery under spinal anaesthesia.
详细描述
Primary Objective To evaluate the effect of ketamine in reducing tourniquet pain for patients undergoing lower limb surgery under spinal anaesthesia.
Secondary Objective To evaluate the effect of ketamine in attenuating TIH for patients undergoing lower limb surgery under spinal anaesthesia.
This will be a prospective, double blind, randomised controlled trial by multiple operators, who are medical officers in the Department of Anaesthesia, University Malaya Medical Centre. 60 patients will be recruited into the study. All patients recruited will be subjected to standard dose of spinal anaesthesia and randomly assigned into 2 different groups.
Methodology Patients will be fasted for at least 6 hours prior to their surgery. Oral midazolam 7.5 mg will be given to healthy adult from age 18-60 and 3.75mg will be given to adult age range from 60-65years as premedication prior to sending patients to the operating theatre.
Patients will be randomly assigned by principal investigator into one of two groups by using computer generated randomized numbers:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II
- •Age between 18-65 years old undergoing lower limb surgeries under spinal anaesthesia with pneumatic tourniquet inflation time more than 60 minutes
排除标准
- •Allergic to ketamine
- •Patients who have any degree of heart block, cardiovascular diseases, uncontrolled hypertension, severe peripheral vascular disease, sickle cell disease, diabetes neuropathy, deep vein thrombosis and pulmonary embolism, liver and renal impairment.
研究组 & 干预措施
Ketamine arm
Ketamine group will receive an IV infusion of 0.25mg/kg of ketamine in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure patients will receive 0.25mg/kg of ketamine infusion at 10ml/hour until the end of operation.
干预措施: Ketamine (Drug)
Control arm
Control group will receive an intravenous (IV) infusion of 10 ml of normal saline in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure, patients will receive 10ml/hour normal saline infusion until the end of operation.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change in pain scores among patients in ketamine group vs patients in saline group, for patients undergoing lower limb surgery under spinal anaesthesia.
时间窗: Pain scores will be assessed at baseline and throughout tourniquet application, at 10 minute intervals until 10 minutes after tourniquet deflation.
Pain Score of 10-30mm: Mild pain Pain Score of 40-60mm: Moderate pain Pain Score of 70-100mm: Severe pain
次要结局
- Change in blood pressure in ketamine group vs saline group, for patients undergoing lower limb surgery under spinal anaesthesia.(SBP, DBP, MAP and HR will be assessed at baseline and throughout tourniquet application, at 10 minute intervals until 10 minutes after tourniquet deflation)
研究者
Dr Foo Li Lian
Anaesthesiologist
University of Malaya